Trialintelligence– is an intelligent tool that utilizes our Patient Level data, Site & Investigator Database, Epidemiology data, data from health foundations & societies and Drug sales data to provide optimized solutions and directions for clinical trials. BijaHealth’sTrialintelligence provides knowledge-based, data-driven, modern analytical models to redefine the clinical trial feasibility, protocol strategies and recruitment process. Our mission is to reduce the time, cost, and uncertainty of conducting clinical trials by capitalizing the power of our advanced healthcare data analytics to clinical development strategies. In the US, in spite of having all the information in electronic format, it takes about 4 weeks to identify a site to carry out a particular clinical trial. However, due to the formidable costs and regulations, most of the clinical trials are moving to emerging markets.
The best choice among these is India where, more than 30% of world clinical trials are being carried out. Since the information is not readily available in developing world, it is a daunting task to identify the site, subjects and investigators and the time required for site identification in these places can take upto 8-10 weeks. In this scenario, the BijaHealth’sTrialintelligence can be an immense help. It is the only tool and the only product available at present for the sponsors who are looking to conduct a clinical trial in the emerging markets. With the help of our Trialintelligence, you can reduce the start up time in site identification and feasibility to less than 3 weeks.
The Trialintelligence utilizes advanced algorithms, state of the art analytics to select the sites that meet the sponsor’s criteria. Using the patient level data (demographics, drugs and interventions) and investigator data, Trialintelligence can efficiently select the sites; analyze the suitability with respect to inclusion/exclusion criteria, and optimize the recruitment of subjects and investigators. Thus Trialintelligence makes the whole clinical trial process simpler by efficiently eliminating costly protocol amendments at a later stage. The Trialintelligence employees synchronized and secure electronic data management tools to aggregate the entire data from all these data bases. Deriving its core strengths from the patient registries and physician data baseTrialIntelligence is one of a kind, simple yet intelligent tool that can be deployed for a clinical trial.
Feasibility Studies
Half Knowledge is not only useless but also can translate in to huge financial implications. Having the complete knowledge of the exact number of patients and their location precisely is necessary for any clinical trial. Until recently, the protocol feasibility studies relied on estimates and not based on actual patient data. BijaHealth’sTrialintelligence allows our clients to test every inclusion and exclusion criterion against the single largest database of patients available to determine potential roadblocks in enrollment, retention and the subsequent trial. The fundamental elements of Trialintelligence approach are: Identify key inclusion and exclusion criterion and apply to the subjects eligibility, Study each patient’s retention potential and his/her impact on the pool of other eligible patients, Perform database queries, Gather insight into the feasibility of the protocol as designed and determine how the criteria can be refined to optimize enrollment, all while ensuring that drug safety may be adequately assessed and that the enrolled population can reasonably be expected to reach target study endpoints
Site Identification and Selection
Our main objective is to help the clients locate research physicians with access to large groups of protocol-eligible patients. We use our state of the art search functionality that is embedded in Trialintelligence to specifically search patient diagnoses, prescription data and the outcomes to locate research sites, to Identify physicians who specialize in the diagnoses &treatment of the targeted indication, to Verify the number of available patients with the disease and/or under treatment, to Ascertain preferred treatment options by the physicians, to Maximize the randomization and Minimize redundancy in the pool. We deploy 24/7 support staff to help your scientists, to evaluate and assess any previous research experience of the investigators and to confirm their interest in the protocol and obtain letters of interest. Further, we deploy our legal teams to obtain the governmental approvals for the study thus avoiding start-up and lead-time delays. We ensure that there is no other ongoing clinical trial at the same site to avoid subjects enrolling in more than one study.
Investigation Performance
Most times, after the clinical trial is launched, it runs into unforeseen problems like poor performance of investigators and at least 25% of original sites are closed due to this. Trialintelligence's mission is to lower these inherent risks in site/investigator selection with our proprietary performance prediction model. We depend on the prior performance data, issues related to retention, regulations etc., to identify any flags. This when analyzed in tandem with the trial design optimizes the whole process.
Patient Recruitment
BijaHealthTrialintelligence uses pre-screening activities and a variety of tactics to recruit pre-selected candidates into clinical trials. Our approach has many advantages over traditional media-driven patient recruitment programs, including: We can target the right candidate as we have access to patient segmentation, by disease and/or treatment; Word of mouth and other multiple messaging approaches at wholesale and retail pharmacies and hospitals and community health centers to optimize patient communications; Direct contact to subjects through doctors and counselors. Cultural and traditional touch is our unique capability in bringing patients on board!